A Just-in-Time Adaptive Intervention for Child and Family Mental Health

Not Applicable

Recruiting

• Conditions: Mental Health and Well-being; Family Functioning

• Registration Number: NCT06443918
• Lead Sponsor: Colliga Apps Corp.

Brief Summary

The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention (JITAI). The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it tests are if the app will improve mental health and family functioning. Participants will download an app on their phone and complete JITAI sessions. Researchers will compare intervention and control groups to see if the app improves mental health.

Detailed Description

The following study tests the efficacy of an app-based program designed to improve child and family mental health and well-being. The intervention will include family-based activities for improving child and family mental health and functioning delivered as psychoeducation and activities through the smartphone app, as well as a just-in-time adaptive intervention (JITAI) component where AI analysis for family interactions will be used to provide real-time, dynamic feedback to families. Participants will be informed during consent that they will have a 50-50 chance of receiving the intervention. The study will assess caregiver and child functioning in a variety of domains, such as mental health symptoms, attachment style, and family conflict through a series of baseline and follow-up questionnaires. Caregivers may use their own smartphones, or they will be lent smartphones for the study. Caregivers and children will also be lent Fitbits/Apple Watches. The intervention will last 8 weeks. Data will include daily surveys, daily audio recordings, 15-minute surveys every 2 weeks about their experiences using the app, bi-weekly check-ins, psychoeducational modules, homework activities, JITAI sessions, and passively sensed data. The intervention will be administered through the smartphone app and will include daily 5-15-minute psychoeducation modules and practice sessions and daily JITAI sessions.

Study Timeline

• Study First Submitted: 2024-02-23
• Status Verified: 2024-05
• Study Start: 2024-05-20
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-05
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

Not provided

Exclusion Criteria

• Active suicidal ideation OR
• Active homicidal ideation OR
• Current child abuse OR
• Current violence in the home

Families meeting these exclusion criteria will undergo a clinical risk assessment and be referred for alternative treatment services.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Child mental health symptoms measured by the Child Behavior Checklist	8 weeks	Children in the intervention group will evidence decreased mental health symptoms compared to children in the control group.
Child attachment measured via the Attachment Style Classification Questionnaire for Latency Age Children	8 weeks	Children in the intervention group will evidence increased secure attachment compared to children in the control group.
Parent-child conflict measured via the Parent-Child Conflict Tactics Scale	8 weeks	Children in the intervention group will evidence decreased parent-child conflict compared to children in the control group.

Secondary Outcome Measures

Name	Time	Method
Caregiver mental health measured via the Symptoms Checklist 27-Plus	8 weeks	Caregivers in the intervention group will evidence decreased mental health symptoms compared to caregivers in the control group.
Caregiver attachment measured via the Experiences in Close Relationships Scale	8 weeks	Caregivers in the intervention group will evidence increased secure attachment compared to caregivers in the control group.
Inter-parental conflict measured via the Conflict Tactics Scale	8 weeks	Caregivers in the intervention group will evidence decreased inter-parental conflict compared to caregivers in the control group.

Trial Locations

Locations (2)

Florida International University; 🇺🇸 Miami, Florida, United States

The University of Texas at Austin; 🇺🇸 Austin, Texas, United States